rademikibart add-on treatment of an acute asthma exacerbation (seabreeze stat asthma)

Conditions: Asthma Acute

Summary: this is a phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation

this is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute asthma exacerbation with type 2 inflammation to compare rademikibart plus standard therapy to standard therapy alone (plus placebo), targeting an acute asthma exacerbation in the urgent healthcare setting.

Eligibility criteria:
inclusion criteria: * physician-diagnosed asthma with duration of ≥12 months (based on the gina 2024 guidelines). * currently receiving treatment with low, medium, to high dose ics (equivalent ics doses as per gina 2024 guidelines) in combination with at least 1 additional asthma controller medication for at least 60 days prior to the screening. * must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids (oral or parenteral) within the previous 12 months prior to screening. * for participants who consent/assent to participate in the trial while in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μl within 12 months prior to screening. * current acute asthma exacerbation requiring an urgent healthcare visit for treatment. * peripheral blood eosinophil count of ≥300 cells/µl as part of the assessment of an index acute asthma exacerbation. * requires systemic corticosteroid as soc in the urgent healthcare setting to treat the current acute asthma exacerbation. * fev1 ≥30% predicted prior to receiving ip. exclusion criteria: * regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer. * unstable ischemic heart disease, cardiomyopathy, heart failure (new york heart association class iii or iv), uncontrolled hypertension. * current or former smoker, has a smoking history including: if \<30 years old: smoked for ≥5 pack-years; if ≥30 years old: smoked for ≥10 pack-years * copd and other clinically significant pulmonary disease other than asthma. * known or suspected history of immunosuppression. * history of known immunodeficiency disorder (including hiv-1 or hiv-2). known medical history of hepatitis b or c. * history of alcohol abuse and/or drug abuse within 12 months prior to screening. * history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy \>1 year prior to entry or other malignancies treated with apparent success with curative therapy \>5 years prior to entry. * female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β hcg test prior to randomization. * receipt of any marketed nonbiologic drug that modulates type 2 cytokines (eg, suplatast tosilate) 30 days or 5 half-lives prior to randomization, whichever is longer. * receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer. * live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial. * participants that have been treated with bronchial thermoplasty in the last 12 months prior to visit 1b. * treatment with ocs and/or hospitalization for an exacerbation of asthma less than 4 weeks prior to randomization. * receipt of any investigational nonbiologic drug within 30 days or 5 half-lives prior to randomization, whichever is longer. the above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: acute exacerbation asthma asthma exacerbation cbp-201 rademikibart connect biopharma